Biosimilar biologic drugs: a new frontier in medical care

ABSTRACT

Physicians in training are expected to be aware of the newest developments in patient care. Biologic therapies have changed treatment of many diseases by specifically targeting key disease mediators, but patient access to these therapies can be limited. As patents for the first biologic therapies are expiring, the development and approval of products known as biosimilars is rapidly gaining momentum. A biosimilar is a biologic product that is highly similar to a reference product (a licensed biologic product), notwithstanding minor differences in clinically inactive components. Biosimilars undergo a thorough evaluation compared with the licensed biologic and need to demonstrate comparable clinical pharmacokinetics, efficacy, and safety including immunogenicity. Understanding the processes for new drug approvals, the rigorous evaluation of biosimilars, and considerations about their selection and use can help recently trained physicians to make informed treatment decisions and improve patient outcomes.

KEYWORDS:

• Biosimilars
• biologic therapy
• drug development
• regulatory approval

Acknowledgments

Medical writing support was provided by Christina McManus of Engage Scientific Solutions and funded by Pfizer Inc.

Declaration of interest

D Geynisman participated at advisory board meetings for Pfizer and received non-financial assistance in the form of medical writing. G de Velasco has received consulting fees and/or participated at advisory board meetings for Bayer, Janssen, Novartis, and Pfizer. K Lea Sewell and I Jacobs are full-time employees of and hold stock or stock options in Pfizer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This manuscript is funded by Pfizer.